The goal of this study is to evaluate the effectiveness and safety of field-initiated magnesium sulfate in improving the long-term functional outcome of patients with acute stroke.
Stroke is the third leading cause of death and the leading cause of adult disability in the United States. Each year, more than 750,000 Americans suffer a symptomatic stroke.
Currently, tissue plasminogen activator (rt-PA) is the only approved treatment for acute ischemic stroke; however, its usefulness is limited because most patients cannot reach medical attention within the necessary 3-hour time window. In addition, rt-PA cannot be given in the field because it is contraindicated for treatment of patients with brain hemorrhage.
The purpose of this multi-center, randomized, double-blind trial is to demonstrate that paramedic initiation of the neuroprotective agent magnesium sulfate in the field is an effective and safe treatment for acute stroke. This study will analyze magnesium sulfate, an experimental therapy for stroke, versus placebo among ambulance-transported patients with acute stroke. This trial will also demonstrate that paramedics can safely, effectively, and rapidly start neuroprotective therapies for stroke.
- Magnesium Drug
Intervention Desc: Ion channel blocker (blocks voltage gated calcium channels and NMDA receptors)
- Normal Saline Drug
Intervention Desc: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours. ARM 1: Kind: Experimental Label: Normal saline
- Magnesium sulfate Drug
Other Names: Epsom salt; Magnesium sulphate Intervention Desc: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours. ARM 1: Kind: Experimental Label: Magnesium Sulfate
- Allocation: Randomized
- Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
- Purpose: Treatment
- Endpoint: Efficacy Study
- Intervention: Parallel Assignment
After being assessed for possible stroke, eligible patients will be randomized to receive either intravenous magnesium sulfate or a matched placebo. Half of the participants will be treated within one hour of stroke, and half will be treated within 1 - 2 hours. Patients in the treatment group will receive a 4-gram bolus dose of magnesium (Mg) delivered over 15 minutes by paramedics in the field, followed by an in-hospital infusion of 16 grams Mg delivered over 24 hours. Patients in the control group will receive placebo on an identical time schedule. Patients will be followed for 90 days.
|Type||Measure||Time Frame||Safety Issue|
|Primary||Functional outcome at 90 days, as measured by the modified Rankin scale (MRS).|
|Secondary||Neurological deficit, as measured by the National Institutes of Health Stroke Scale (NIHSS), disability, as defined by the Barthel Index (BI), and quality of life, as assessed by the Stroke Impact Scale (SIS).|
|Primary||The primary endpoint is the modified Rankin Scale global measure of global disability, assessed 90 days after treatment.||3 months after stroke onset||No|
|Secondary||Barthel Index measure of activities of daily living||3 months||No|
|Secondary||NIH Stroke Scale measure of neurologic deficit||3 months||No|
|Secondary||Stroke Impact Scale measure of stroke-specific quality of life||3 months||No|
|Secondary||Symptomatic hemorrhagic transformation||4 days||Yes|
|Secondary||Recurrent ischemic stroke||90 days||Yes|
|Primary||Modified Rankin Scale||3 months after stroke onset||No|
|Secondary||Modified Rankin Score of 0 or 1||3 months||No|
|Secondary||Modified Rankin Score ≤2||3 months||No|
|Secondary||NIH Stroke Scale||3 months||No|
|Secondary||Barthel Index||3 months||No|
|Secondary||Stroke Impact Scale||3 months||No|
|Secondary||Serious Adverse Events||3 months||Yes|
|Secondary||Symptomatic Intracranial Hemorrhage||3 month||Yes|